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市場調査レポート

世界のHIV診断・治療市場

Diagnostics and Therapeutics for HIV: Global Markets

発行 BCC Research 商品コード 180820
出版日 ページ情報 英文 163 Pages
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世界のHIV診断・治療市場 Diagnostics and Therapeutics for HIV: Global Markets
出版日: 2014年04月11日 ページ情報: 英文 163 Pages
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概要

世界のHIV治療・診断市場は、2013年の182億米ドルからCAGR1.5%で成長し、2018年に186億米ドルに達すると予測されています。

当レポートでは、世界のHIV治療・診断市場について調査し、市場の概要、実績データ・推計・CAGR予測を含めた市場動向の分析、先進療法・診断手法における改善の分析、世界のさまざまな国々における治療コストの意味合いに関する議論、現在進行中の研究と将来の市場方向性の調査、および市場参入企業のプロファイルなどを提供しており、概略下記の構成でお届けします。

第1章 イントロダクション

第2章 サマリー

第3章 概要

  • 世界のHIV負担
  • 世界のHIVまん延への反応
  • HIV研究における画期的な出来事
  • HIVライフサイクルの標的
  • HIV感染検出用の診断ツール
  • HIV予防薬への取り組み
  • 世界のHIV市場の将来
  • 結論

第4章 世界市場

  • 世界のHIV市場
  • 世界のHIV市場予測
  • HIV市場:地域別
  • 北米のHIV市場
  • 欧州のHIV市場
  • 欧州のHIV市場動向
  • 市場予測
  • アジアのHIV市場
  • アジアのHIV市場動向
  • その他地域のHIV市場
  • HIV研究への世界的な投資
  • HIV治療への投資
  • HIVワクチンへの投資
  • HIV予防薬への投資
  • HIV診断への投資
  • HIV関連のその他の調査への投資
  • ジェネリックHIV治療薬市場
  • ジェネリックHIV治療薬市場の成長促進因子
  • ジェネリックHIV治療薬市場の成長阻害因子

第5章 HIV治療薬市場:主要ARV治療薬分類

  • 治療:治療ライン別
  • 一次療法計画
  • 二次療法計画
  • 三次/サルベージ療法計画
  • ARV市場:薬剤分類別
  • NRTIs(ヌクレオシド系逆転写酵素阻害薬)
  • NNRTIs(非核酸系逆転写酵素阻害剤)
  • プロテアーゼ阻害薬
  • インテグラーゼ鎖移転阻害薬
  • 侵入阻害剤
  • 単一錠剤計画(STR)多剤混合薬(FDC)

第6章 HIV治療薬市場:主要治療薬

  • 8つの主要薬剤が市場シェアの80%以上を獲得
  • ATRIPLA
  • TRUVADA
  • EPZICOM
  • VIREAD
  • PREZISTA
  • REYATAZ
  • KALETRA
  • ISENTRESS
  • 有望な新しい治療法
  • その他の治療薬

第7章 ARV治療薬パイプライン分析

  • 開発中のNRTI治療薬
  • 開発中のNNRTIs
  • MK1439
  • RILPIVIRINE (LA)
  • 開発中のインテグラーゼ阻害薬
  • 開発中の侵入阻害剤
  • 併用療法
  • 572 TRII
  • 開発中のその他のSTR FDC薬剤
  • 開発中の薬物動態ブースター
  • SB-728-T
  • KP-1461
  • LEXGENLEUCEL-T (VRX-496)
  • SL9-TCR 遺伝子療法
  • 免疫刺激剤
  • 抗HIVモノクロナール抗体

第8章 HIV検査・診断

  • 早期発見
  • 患者病期診断
  • 治療切り替え
  • 主な迅速HIV検査
  • 主なCD4検査
  • 主なウィルス量検査
  • HIV診断パイプライン
  • HIV診断市場
  • 迅速HIV検査市場
  • CD4検査市場
  • ウィルス量検査市場

第9章 HIV予防薬

  • 暴露に基づいたHIV予防薬
  • 早期予防薬
  • 暴露前予防薬
  • 殺菌剤・膣リング
  • 包皮切除術
  • 暴露後予防
  • 母子感染の予防

第10章 HIVワクチン

  • HIVワクチン開発の障壁
  • 予防vs.治療用HIVワクチン
  • HIVワクチンの種類
  • 過去のRV144試験
  • HIVワクチン研究における近年の進歩

第11章 定性分析

第12章 企業プロファイル

第13章 付録A:用語

第14章 付録B:薬剤の頭字語

第15章 付録C:略語

図表

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目次
Product Code: PHM058B

The global market for HIV therapeutics and daignostics is expected to grow to $18.2 billion in 2013 and $19.6 in 2018, with a compound annual growth rate (CAGR) of 1.5%.

This report provides:

  • An overview of the global market for HIV therapeutics and diagnostics
  • Analyses of global market trends, with data from 2013, and estimates and projections of CAGRs through 2018.
  • Discussion of improvements in advanced treatments and diagnostic methods.
  • Examination of cost implications for treatments accross a wide range of countries
  • A look at ongoing research and the future direction of the market.

STUDY GOALS AND OBJECTIVES

The aim of this report is to provide detailed market, technology and industry analyses to help readers quantify and qualify the market for products used in the treatment, testing and prophylaxis of HIV/AIDS. Important trends are identified and sales forecasts by product categories and major country markets are provided through 2018; these are based on industry sources and considered assessment of the regulatory environment, health-care policies, demographics and other factors that directly affect the HIV/AIDS market. The wider economic environment is also taken into account.

REASONS FOR DOING THE STUDY

HIV/AIDS is one of the most catastrophic threats to human health throughout the world. Advanced treatment options and improved methods of diagnosis have helped to moderate the growth of the epidemic and this has presented opportunities for companies prepared to engage actively in this field. However, the management of HIV/AIDS is still, in many respects, an unfulfilled market and there is an ongoing, urgent need for promising new research directions as well as optimal exploitation of the treatment and diagnostic options already developed. In this dynamic and continually evolving marketplace, there is a need for an up-to-date, comprehensive appraisal covering both strategic and tactical options confronting the pharmaceutical industry.

SCOPE AND FORMAT

This report summarizes the market of HIV/AIDS products and discusses the present status and evolution of antiretroviral (ARV) drugs with analyses by selected major national markets. The latest treatment and diagnostic options and practices are described and their cost implications clarified, especially in the context of treatment affordability in countries of widely varying economic status. The emergence of a considerable generic medicine component in the marketplace, alongside the presence of original branded medicines, is discussed. The current market for antiretroviral therapies is analyzed, with breakdowns by drug categories, and the leading drugs of 2012 are discussed. Five-year forecasts are provided with reasonable explanations. This report also summarizes the research efforts in early HIV prophylaxis, including pre-exposure prophylaxis, post-exposure prophylaxis and prevention of HIV transmission from mother to infant. Finally, major research efforts for developing HIV vaccines are summarized and promising directions are identified.

ANALYST'S CREDENTIALS

Kritika Chaudhari is an independent research analyst and has written extensively about a wide range of therapeutic areas. She has worked in laboratory research settings in the United States and the United Kingdom, and now provides market analysis and intellectual property due-diligence services as a freelance consultant, specializing in early-stage and emerging research in the biotechnology and pharmaceuticals industries.

Table of Contents

CHAPTER 1 - INTRODUCTION

  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR DOING THE STUDY
  • INTENDED AUDIENCE
  • SCOPE AND FORMAT
  • METHODOLOGY
  • ANALYST'S CREDENTIALS
  • INFORMATION SOURCES
  • MARKET ANALYSES AND FORECASTS
  • RELATED BCC RESEARCH REPORTS
  • BCC RESEARCH ONLINE SERVICES
  • DISCLAIMER

CHAPTER 2 - SUMMARY

  • THE SKEWED MARKET
  • HIV THERAPEUTICS MARKET WILL BE WORTH $19.6 BILLION IN 2018
  • FIXED-DOSE COMBINATION DRUGS AND INTEGRASE INHIBITOR DRUGS WILL DRIVE THE MARKET
  • 2013 WHO GUIDELINES WILL EXPAND THE GLOBAL HIV MARKET
  • STRICT ADHERENCE TO ARV TREATMENT REMAINS A CHALLENGE
  • DEMAND FOR ACCESS TO AFFORDABLE MEDICINE
  • SEVEN OF THE EIGHT LEADING ARV DRUGS ARE ON PATENT CLIFF
  • GILEAD SCIENCES WILL CONTINUE TO DOMINATE THE HIV THERAPEUTICS MARKET
  • POC DEVICES FOR CD4 AND VIRAL LOAD TESTING WILL DRIVE THE HIV DIAGNOSTICS MARKET
  • THE U.S. WILL REMAIN THE LEADING NATIONAL MARKET FOR HIV
  • EARLY PROPHYLAXIS IS THE KEY TO HIV MANAGEMENT
  • HIV VACCINES-A LONG ROAD AHEAD
  • TOWARDS AN AIDS-FREE GENERATION
  • SUMMARY TABLE: GLOBAL HIV MARKET, THROUGH 2018 ($ BILLIONS)
  • SUMMARY FIGURE: GLOBAL HIV MARKET, 2012-2018 ($ BILLIONS)

CHAPTER 3 - OVERVIEW

  • GLOBAL BURDEN OF HIV
    • TABLE 1: TOP 10 LEADING CAUSES OF DEATHS IN THE WORLD, 2011 (MILLIONS)
    • TABLE 2: BURDEN OF HIV BY GEOGRAPHICAL REGIONS
  • GLOBAL RESPONSE TO HIV EPIDEMIC
  • MILESTONES IN HIV RESEARCH
    • TABLE 3: MILESTONES IN THE HISTORY OF HIV
  • TARGETING HIV LIFECYCLE
    • TABLE 4: LIFE CYCLE OF HIV-THERAPEUTICS TARGET POINTS
  • DIAGNOSTIC TOOLS FOR DETECTING HIV INFECTION
  • EFFORTS FOR HIV PROPHYLAXIS
  • FUTURE OF GLOBAL HIV MARKET
  • CONCLUSION

CHAPTER 4 - GLOBAL MARKET

  • GLOBAL HIV MARKET 2012
  • GLOBAL HIV MARKET FORECAST TO 2018
    • TABLE 5: FORECASTED NUMBER OF PEOPLE RECEIVING ARV THERAPY, 2012-2018 (MILLIONS)
  • HIV MARKET BY GEOGRAPHICAL REGIONS
    • TABLE 6: ARV DRUGS SALES REVENUE BY GEOGRAPHIC REGIONS, THROUGH 2018 ($ BILLIONS)
    • TABLE 7: ARV DRUGS MARKET SHARE BY GEOGRAPHIC REGIONS, 2012-2018 (%)
    • FIGURE 1: ARV DRUGS SALES REVENUE BY GEOGRAPHIC REGIONS, 2012-2018 ($ BILLIONS)
  • NORTH AMERICAN HIV MARKET
    • REGULATIONS IMPACTING THE GROWTH OF NORTH AMERICAN HIV MARKET
    • MARKET FORECAST
  • EUROPEAN HIV MARKET
    • TABLE 8: EUROPEAN COUNTRIES BY RATES OF HIV DIAGNOSIS (%)
    • TABLE 9: PATTERN OF HIV INFECTION BY EUROPEAN REGIONS, 2012
  • TRENDS IN EUROPEAN HIV MARKET
    • TABLE 10: SALES REVENUE OF ARV DRUGS IN EU5 COUNTRIES, THROUGH 2018 ($ BILLIONS)
    • TABLE 11: HIV THERAPEUTICS MARKET SHARE BY EU5 COUNTRIES, 2012-2018 (%)
    • FIGURE 2: SALES REVENUE OF ARV DRUGS IN EU5 COUNTRIES ($ BILLIONS)
    • TABLE 12: HIV PREVALENCE IN EU5 COUNTRIES, 2012
    • TABLE 13: RATE OF LATE DIAGNOSIS BY REGIONS OF THE U.K. (%)
  • MARKET FORECAST
    • THE ASIAN HIV MARKET
      • TABLE 14: HIV PREVALENCE AND INCIDENCE OF NEW INFECTIONS IN ASIAN COUNTRIES, 2012
      • TABLE 15: SALES REVENUE OF ARV DRUGS IN LEADING ASIAN MARKETS, THROUGH 2018 ($ BILLIONS)
      • TABLE 16: HIV MARKET SHARE BY LEADING ASIAN COUNTRIES, 2012-2018 (%)
      • FIGURE 3: SALES REVENUE OF ARV DRUGS IN LEADING ASIAN MARKETS, 2012-2018 ($ BILLIONS)
  • TRENDS IN THE ASIAN HIV MARKET
    • MARKET FORECAST
  • HIV MARKET IN ROW
    • HIV MARKET TRENDS IN THE ROW
    • MARKET FORECAST
  • GLOBAL INVESTMENT IN HIV RESEARCH
    • TABLE 17: FORECAST GLOBAL ANNUAL INVESTMENT IN HIV RESEARCH, THROUGH 2018 ($ BILLIONS)
    • TABLE 18: GLOBAL INVESTMENT SHARE BY AREA OF RESEARCH, 2012-2018 (%)
    • TABLE 19: INVESTMENT BY DONOR TYPE (%)
  • INVESTMENT IN HIV THERAPEUTICS
    • TABLE 20: INVESTMENT IN HIV THERAPEUTICS BY DRUG SUBCATEGORIES IN 2012 (%)
  • INVESTMENT IN HIV VACCINES
  • INVESTMENT IN HIV PROPHYLAXIS
    • TABLE 21: INVESTMENT BY MODE OF HIV PROPHYLAXIS (%)
  • INVESTMENT IN HIV DIAGNOSTICS
  • INVESTMENT FOR OTHER RESEARCH ASSOCIATED WITH HIV
  • GENERIC HIV DRUGS MARKET
    • FIGURE 4: GENERIC VS. BRANDED ARV DRUGS GLOBAL SALES REVENUE, 2012-2018 ($ BILLIONS)
    • FIGURE 5: GENERIC ARV DRUGS GLOBAL SALES REVENUE GROWTH ($ MILLIONS/%)
  • DRIVERS FOR THE GROWTH OF GENERIC HIV DRUGS MARKET
    • TABLE 22: LEADING ARV DRUGS ON PATENT CLIFF
  • RESTRAINTS TO THE GROWTH OF GENERIC HIV DRUGS MARKET
    • TABLE 23: DRIVERS AND RESTRAINTS OF GENERIC HIV MARKET

CHAPTER SUMMARY

  • TABLE 24: DRIVERS AND RESTRAINTS OF GLOBAL HIV MARKET

CHAPTER 5 - HIV THERAPEUTICS MARKET: LEADING ARV DRUG CATEGORIES

  • THERAPY BY LINE-TREATMENT
    • TABLE 25: RECOMMENDED ARV TREATMENT BY THE WHO
  • FIRST-LINE TREATMENT REGIMEN
  • SECOND-LINE TREATMENT REGIMEN
  • THIRD-LINE/SALVAGE TREATMENT REGIMEN
  • ARV MARKET BY DRUG CATEGORIES
    • TABLE 26: HIV THERAPEUTICS MARKET BY DRUG CATEGORY, THROUGH 2018 ($ BILLIONS)
    • TABLE 27: HIV THERAPEUTICS MARKET SHARE BY DRUG CATEGORY, 2012-2018 (%)
    • FIGURE 6: HIV THERAPEUTICS MARKET BY DRUG CATEGORY 2012-2018 (%)
  • NRTIS
    • TABLE 28: LIST OF APPROVED NRTIS (AND TABLE UNITS)
    • Mechanism of Action:
    • Resistance to NRTIs
    • Market Status
    • Market Forecast
  • NNRTIS
    • TABLE 29: LIST OF APPROVED NNRTIS
    • Mechanism of Action
    • Drug Resistance and Adverse Effects
    • Market Status
    • Market Forecast
  • PROTEASE INHIBITORS
    • TABLE 30: LIST OF APPROVED PROTEASE INHIBITORS
    • Pharmacokinetic Boosters
    • Market Forecast
  • INTEGRASE STRAND TRANSFER INHIBITORS
    • TABLE 31: LIST OF APPROVED INTEGRASE INHIBITOR DRUGS
    • Market Forecast
  • ENTRY INHIBITORS
    • TABLE 32: LIST OF APPROVED ENTRY INHIBITORS
    • Mechanism of Action
    • Market Forecast
  • SINGLE TABLET REGIMEN (STR) FIXED-DOSE COMBINATION (FDC) DRUGS
    • TABLE 33: LIST OF APPROVED STR FDC DRUGS
    • Market Forecast

CHAPTER SUMMARY

  • TABLE 34: MARKET DRIVERS AND RESTRAINTS OF ARV DRUGS, BY CLASS

CHAPTER 6 - HIV THERAPEUTICS MARKET: LEADING DRUGS

  • LEADING EIGHT HIV DRUGS CLAIMED OVER 80% OF THE MARKET SHARE
    • TABLE 35: SALES REVENUE FORECAST OF LEADING HIV DRUGS, THROUGH 2018 ($ BILLIONS)
    • TABLE 36: HIV MARKET SHARE BY LEADING DRUGS (%)
    • FIGURE 7: HIV MARKET SHARE BY LEADING DRUGS (%)
  • ATRIPLA
    • Generic Atripla for PEPFAR Countries
    • Competitors
    • Market Forecast
  • TRUVADA
    • Truvada as a Prophylactic Drug
    • Market Forecast
  • EPZICOM
    • HLA-B*5701 Testing
    • Clinical Trials
    • Patents and Competition
    • Market Forecast
  • VIREAD
    • Viread Prodrug
    • Market Forecast
  • PREZISTA
    • Clinical Trials
    • Patents
    • Competitors
    • Market Forecast
  • REYATAZ
    • Competitors
    • Market Forecast
  • KALETRA
    • Competitors
    • Market Forecast
  • ISENTRESS
    • Clinical Trials
    • Competitors
    • Market Forecast
  • PROMISING EMERGING THERAPIES
    • STRIBILD
      • Clinical Trials
      • Competitors
      • Market Forecast
    • TIVICAY
      • Clinical Trials
      • Competitors
      • Market Forecast
    • COMPLERA
      • Clinical Trials
      • Patent
      • Market Forecast
    • INTELENCE
      • Market Forecast
  • OTHER DRUGS
    • COMBIVIR
      • Competition
    • SUSTIVA
    • NORVIR
    • SELZENTRY
      • Clinical Trials
      • Market Forecast
    • OTHER ARV DRUGS IN THE MARKET

CHAPTER SUMMARY

  • FIGURE 8: RANKING (BY MARKET SHARE) OF LEADING ARV DRUGS, 2012-2018
  • TABLE 37: MARKET DRIVERS AND RESTRAINTS OF THE LEADING ARV DRUGS

CHAPTER 7 - ARV DRUGS PIPELINE ANALYSIS

  • FIGURE 9: NUMBER OF CLINICAL TRIALS BY DEVELOPMENTAL PHASE
  • NRTI DRUGS IN DEVELOPMENT
    • TENOFOVIR ALAFENAMIDE (TAF)
      • Clinical Trials
      • Market Potential
  • NNRTIS IN DEVELOPMENT
    • TABLE 38: ONGOING CLINICAL TRIALS OF NNRTI DRUGS IN DEVELOPMENT
  • MK1439
    • Clinical Trials
    • Market Potential
  • RILPIVIRINE (LA)
    • Clinical Trials
    • Market Potential
  • INTEGRASE INHIBITORS IN DEVELOPMENT
    • S/GSK1265744
      • Clinical Trials
      • Market Potential
  • ENTRY INHIBITORS IN DEVELOPMENT
    • CENICRIVIROC
      • Clinical Trials
      • Market Potential
    • ALBUVIRTIDE
      • Clinical Trials
      • Market Potential
    • BMS-663068
  • COMBINATION THERAPIES
    • TABLE 39: ONGOING CLINICAL TRIALS OF STR FDC DRUGS
  • 572 TRII
    • Clinical Trials
    • Market Potential
  • OTHER STR FDC DRUGS IN DEVELOPMENT
  • PHARMACOKINETIC BOOSTERS IN DEVELOPMENT
  • EMERGING THERAPIES
    • TABLE 40: ONGOING CLINICAL TRIALS OF EMERGING THERAPIES
  • SB-728-T
    • Clinical Trials
    • Market Potential
  • KP-1461
    • Clinical Trials
  • LEXGENLEUCEL-T (VRX-496)
    • Clinical Trials
    • Market Potential
  • SL9-TCR GENE THERAPY
    • Clinical Trials
  • IMMUNOMODULATORS
  • MONOCLONAL ANTIBODIES AGAINST HIV

CHAPTER SUMMARY

  • TABLE 41: OVERVIEW OF ARV DRUGS IN DEVELOPMENT

CHAPTER 8 - HIV TESTING AND DIAGNOSTICS

  • EARLY DETECTION
  • PATIENT STAGING
  • TREATMENT SWITCHING
    • HIV SCREENING TESTS
    • HIV CONFIRMATORY TESTS
    • HIV MONITORING TESTS
  • TYPES OF HIV TESTS
    • ANTIGEN- AND ANTIBODY-BASED TESTS FOR HIV
      • TABLE 42: HIV RAPID TESTS ADVANTAGES AND DISADVANTAGES BY CLIA* COMPLEXITY AND GENERATION
      • TABLE 43: FDA APPROVED ANTIBODY HIV TESTS
      • TABLE 44: FDA APPROVED ANTIGEN-ANTIBODY COMBO TESTS
    • CD4 TESTING
      • TABLE 45: CD4 TESTS IN THE MARKET
    • VIRAL LOAD TESTING
      • TABLE 46: LIST OF MARKETED VIRAL LOAD TESTS
  • SELECTED RAPID HIV TESTS
    • ALERE DETERMINE HIV-1/2 AG/AB COMBO TEST
    • CHEMBIO'S DPP(R) HIV 1/2 ASSAY
    • CLEARVIEW ® HIV 1/2 STAT-PAK ®
    • REVEAL G3 RAPID HIV-1 ANTIBODY TEST
    • PRISM HIV AG/AB COMBO ASSAY
  • SELECTED CD4 TESTS
    • BD FACSCALIBURc™ FLOW CYTOMETER
    • CYTOMICS FC 500c™ MCL/MPL SYSTEM
    • CYFLOW COUNTER
    • MILLIPORE-GUAVA AUTO CD4/CD4% SYSTEM
    • APOGEE AUTO40 FLOW CYTOMETER
    • AQUIOS CL
    • POINT OF CARE CD4 TESTING ASSAYS
      • PointCare NOW
      • Pima CD4 Analyser
      • CyFlowTM CD4 miniPOC
  • SELECTED VIRAL LOAD TESTS
    • COBAS AMPLIPREP/COBAS TAQMAN HIV-1 SYSTEM
    • ABBOTT REALTIME HIV-1
    • VERSANT HIV RNA 1.0 (KPCR)
    • ARTUS HIV-1 RS/QS-RGQ KIT
    • NUCLISENS EASYQ HIV-1
    • VERSANT® HIV-1 RNA 3.0 ASSAY
    • NON-NUCLEIC ACID-BASED VIRAL LOAD ASSAYS
      • ExaVir Load Version 3.0
  • HIV DIAGNOSTICS PIPELINE
    • TABLE 47: HIV/AIDS DIAGNOSTICS PIPELINE
    • DAKTARI CD4 COUNTER
    • MBIO CD4 SYSTEM
    • VISITECT CD4
    • ZYOMYX MYT4 TEST
    • ALERE'S NAT SYSTEM
    • LIAT ANALYSER
    • SAMBA
    • EOSCAPE-HIV RAPID RNA ASSAY SYSTEM
    • LYNX HIV P24 ANTIGEN ASSAY
    • PANNAT PLATFORM
  • HIV DIAGNOSTICS MARKET
    • TABLE 48: HIV DIAGNOSTICS MARKET BY TYPES OF TESTS, THROUGH 2018 ($ BILLIONS)
    • TABLE 49: HIV DIAGNOSTICS MARKET SHARE BY TYPES OF TESTS, 2012-2018 (%)
  • RAPID HIV TESTING MARKET
    • Forecast for Rapid HIV Testing Market
  • CD4 TESTING MARKET
    • TABLE 50: CD4 TESTING MARKET SHARE IN SEVEN SUB-SAHARAN AFRICAN COUNTRIES, 2012 (%)
    • Forecast for CD4 Testing Market
      • TABLE 51: GLOBAL DEMAND FOR CD4 TESTING, 2012-2018 (MILLIONS)
  • VIRAL LOAD TESTING MARKET
    • Forecast for Viral Load Testing Market
      • TABLE 52: GLOBAL DEMAND FOR VIRAL LOAD TESTING, 2012-2018 (MILLIONS)

CHAPTER SUMMARY

  • TABLE 53: MARKET DRIVERS AND RESTRAINTS FOR HIV TESTING PRODUCTS

CHAPTER 9 - HIV PROPHYLAXIS

  • HIV PROPHYLAXIS BASED ON EXPOSURE
  • EARLY PROPHYLAXIS
  • PRE-EXPOSURE PROPHYLAXIS
    • CLINICAL STUDIES IN SUPPORT OF HIV PREP
      • Bangkok Tenofovir Study
      • HPTN 052
      • PopART Study
    • LONG ACTING FORMULATIONS OF EXISTING ARV DRUGS
      • TABLE 54: CLINICAL TRIALS TESTING DRUG-BASED PREP, 2014 AND 2015
  • MICROBICIDES AND VAGINAL RINGS
    • Centers for Disease Control and Prevention
    • Failure of the VOICE Trial
    • CAPRISA
    • ASPIRE and "IPM 027"
      • TABLE 55: ONGOING CLINICAL TRIALS OF MICROBICIDES, 2014 AND 2015
  • MALE CIRCUMCISION
  • POST-EXPOSURE PROPHYLAXIS (PEP)
  • PREVENTING TRANSMISSION FROM MOTHER TO CHILD
    • TABLE 56: EVOLUTION OF WHO GUIDELINES WITH REGARDS TO PMTCT, 2006-2013
    • TABLE 57: SELECTED ON-GOING TRIALS ON PMTCT, 2013-2017

CHAPTER SUMMARY

CHAPTER 10 - HIV VACCINES

  • HURDLES FOR DEVELOPING HIV VACCINES
  • PROPHYLACTIC VS. THERAPEUTIC HIV VACCINES
  • TYPES OF HIV VACCINES
    • TABLE 58: TYPE OF HIV VACCINES
  • THE HISTORIC RV144 TRIAL
  • RECENT ADVANCES IN HIV VACCINE RESEARCH
    • GEOVAX'S PROPHYLACTIC AND THERAPEUTIC VACCINE DUAL
    • TECHNOLOGY
      • TABLE 59: ONGOING CLINICAL TRIALS OF PROPHYLACTIC HIV VACCINES
      • TABLE 60: ONGOING CLINICAL TRIALS FOR THERAPEUTIC HIV VACCINES
    • FUTURE HOPES OF A SUCCESSFUL HIV VACCINE

CHAPTER 11 - QUALITATIVE ANALYSIS

  • PORTER'S 5 ANALYSIS
    • FIGURE 10: GLOBAL HIV THERAPEAUTICS MARKET ANALYSIS
  • COMPETITIVE RIVALRY WITHIN INDUSTRY
  • THREAT OF NEW ENTRANTS
  • THREAT OF SUBSTITUTE PRODUCTS
    • Leading Drugs on Patent Cliff
    • Drug Counterfeiting
  • BARGAINING POWER OF SUPPLIERS
  • BARGAINING POWER OF CUSTOMERS
    • TRIPS Flexibilities
      • Compulsory Licensing and Parallel Imports
      • Negotiations for Low-Priced Drugs
      • Promoting Free Trade
      • Patents for Public Health
  • CHALLENGES OF THE HIV MARKET
    • ACCESSIBILITY TO ARV THERAPY
    • ADHERENCE TO DRUG REGIMENS
      • TABLE 61: RETENTION TO TREATMENT (%)
    • P4P4P
      • Combination Pills
    • HIGH COST OF TREATMENT
      • First-Line vs. Second-Line Treatment
        • TABLE 62: FIRST-LINE VS. SECOND-LINE TREATMENT MEDIAN PRICE, 2012 (IN $US PER PERSON PER YEAR)
      • Cost of STR FDC Pills
    • PEDIATRIC FORMULATIONS OF ARV DRUGS
    • LATE DIAGNOSIS OF HIV INFECTION
    • ACCESSIBILITY TO HIV DIAGNOSTICS
    • COMPLEXITY OF VIRAL LOAD TESTING
    • ADHERENCE CHALLENGES IN PRE-EXPOSURE PROPHYLAXIS
    • REGULATORY AND POLITICAL CHALLENGES
    • HIGH VARIABILITY OF HIV
  • OPPORTUNITIES FOR REVENUE GENERATION
    • DRUGS FOR TREATMENT-EXPERIENCED PATIENTS
    • DRUGS WITH LONG HALF-LIFE
    • EARLY INFANT DIAGNOSIS
    • PREVENTING TREATMENT SWITCHES
    • DECENTRALIZATION OF HIV TESTING
    • DEMAND FOR SIMPLE, IMPROVED LOW-COST TESTING DEVICES
  • DRIVERS OF THE HIV MARKET
    • LONGEVITY OF HIV-INFECTED PATIENTS
    • INCREASE IN AWARENESS PROGRAMS
    • INCREASE IN ACCESS TO THERAPEUTICS AND DIAGNOSTICS
    • FOURTH-GENERATION RAPID HIV TESTING
    • POINT-OF-CARE DIAGNOSTICS
  • IMPLICATIONS OF RECENT REGULATORY GUIDELINES
  • RESTRAINTS TO THE GROWTH OF HIV MARKET
    • SOCIAL STIGMA ASSOCIATED WITH HIV TESTING
    • HIGH PRICE FOR NEW DRUGS EVENTUALLY REDUCING THEIR UPTAKE
    • PMTCT WILL REDUCE PEDIATRIC HIV MARKET
    • ECONOMIC SLOWDOWN
  • HARMONIZATION
    • PUBLIC-PRIVATE PARTNERSHIPS
    • CORPORATE RESPONSIBILITY
    • HARMONY AMONG REGULATORY AGENCIES

CHAPTER SUMMARY

  • TABLE 63: CHALLENGES AND OPPORTUNITIES IN THE GLOBAL HIV MARKET
  • TABLE 64: MAJOR DRIVERS AND RESTRAINTS IN THE GLOBAL HIV MARKET

CHAPTER 12 - COMPANY PROFILES

  • HIV THERAPEUTICS-LEADING COMPANIES
    • TABLE 65: HIV THERAPEUTICS MARKET SHARE BY LEADING COMPANIES, 2012-2018 ($ BILLIONS)
    • FIGURE 11: HIV THERAPEUTICS MARKET SHARE BY LEADING COMPANIES (%)
  • ABBVIE INC
  • BRISTOL-MYERS SQUIBB
    • Bristol-Myers Squibb Pharmaceuticals Limited (Uxbridge)
  • GILEAD SCIENCES
  • JANSSEN THERAPEUTICS
  • MERCK & CO. INC
  • VIIV HEALTHCARE
    • U.S. headquarters
  • HIV DIAGNOSTICS: LEADING COMPANIES
    • ABBOTT LABORATORIES
    • ALERE
    • BD BIOSCIENCES
    • BD
    • ROCHE
    • SIEMENS HEALTHCARE DIAGNOSTICS
  • SELECTED EMERGING AND GENERIC COMPANIES IN THE GLOBAL HIV MARKET
    • ASPEN GROUP
    • KORONIS PHARMACEUTICALS (VDA PHARMA)
    • MYLAN
    • SANGAMO BIOSCIENCES

CHAPTER 13 - APPENDIX A: GLOSSARY

  • TABLE 66: GLOSSARY

CHAPTER 14 - APPENDIX B: DRUG ACRONYMS

CHAPTER 15 - APPENDIX C: ABBREVIATIONS

  • TABLE 67: ABBREVIATIONS

LIST OF TABLES

  • SUMMARY TABLE: GLOBAL HIV MARKET, THROUGH 2018 ($ BILLIONS)
    • TABLE 1: TOP 10 LEADING CAUSES OF DEATHS IN THE WORLD, 2011 (MILLIONS)
    • TABLE 2: BURDEN OF HIV BY GEOGRAPHICAL REGIONS
    • TABLE 3: MILESTONES IN THE HISTORY OF HIV
    • TABLE 4: LIFE CYCLE OF HIV-THERAPEUTICS TARGET POINTS
    • TABLE 5: FORECASTED NUMBER OF PEOPLE RECEIVING ARV THERAPY, 2012-2018 (MILLIONS)
    • TABLE 6: ARV DRUGS SALES REVENUE BY GEOGRAPHIC REGIONS, THROUGH 2018 ($ BILLIONS)
    • TABLE 7: ARV DRUGS MARKET SHARE BY GEOGRAPHIC REGIONS, 2012-2018 (%)
    • TABLE 8: EUROPEAN COUNTRIES BY RATES OF HIV DIAGNOSIS (%)
    • TABLE 9: PATTERN OF HIV INFECTION BY EUROPEAN REGIONS, 2012
    • TABLE 10: SALES REVENUE OF ARV DRUGS IN EU5 COUNTRIES, THROUGH 2018 ($ BILLIONS)
    • TABLE 11: HIV THERAPEUTICS MARKET SHARE BY EU5 COUNTRIES, 2012-2018 (%)
    • TABLE 12: HIV PREVALENCE IN EU5 COUNTRIES, 2012
    • TABLE 13: RATE OF LATE DIAGNOSIS BY REGIONS OF THE U.K. (%)
    • TABLE 14: HIV PREVALENCE AND INCIDENCE OF NEW INFECTIONS IN ASIAN COUNTRIES, 2012
    • TABLE 15: SALES REVENUE OF ARV DRUGS IN LEADING ASIAN MARKETS, THROUGH 2018 ($ BILLIONS)
    • TABLE 16: HIV MARKET SHARE BY LEADING ASIAN COUNTRIES, 2012-2018 (%)
    • TABLE 17: FORECAST GLOBAL ANNUAL INVESTMENT IN HIV RESEARCH, THROUGH 2018 ($ BILLIONS)
    • TABLE 18: GLOBAL INVESTMENT SHARE BY AREA OF RESEARCH, 2012-2018 (%)
    • TABLE 19: INVESTMENT BY DONOR TYPE (%)
    • TABLE 20: INVESTMENT IN HIV THERAPEUTICS BY DRUG SUBCATEGORIES IN 2012 (%)
    • TABLE 21: INVESTMENT BY MODE OF HIV PROPHYLAXIS (%)
    • TABLE 22: LEADING ARV DRUGS ON PATENT CLIFF
    • TABLE 23: DRIVERS AND RESTRAINTS OF GENERIC HIV MARKET
    • TABLE 24: DRIVERS AND RESTRAINTS OF GLOBAL HIV MARKET
    • TABLE 25: RECOMMENDED ARV TREATMENT BY THE WHO
    • TABLE 26: HIV THERAPEUTICS MARKET BY DRUG CATEGORY, THROUGH 2018 ($ BILLIONS)
    • TABLE 27: HIV THERAPEUTICS MARKET SHARE BY DRUG CATEGORY, 2012-2018 (%)
    • TABLE 28: LIST OF APPROVED NRTIS (AND TABLE UNITS)
    • TABLE 29: LIST OF APPROVED NNRTIS
    • TABLE 30: LIST OF APPROVED PROTEASE INHIBITORS
    • TABLE 31: LIST OF APPROVED INTEGRASE INHIBITOR DRUGS
    • TABLE 32: LIST OF APPROVED ENTRY INHIBITORS
    • TABLE 33: LIST OF APPROVED STR FDC DRUGS
    • TABLE 34: MARKET DRIVERS AND RESTRAINTS OF ARV DRUGS, BY CLASS
    • TABLE 35: SALES REVENUE FORECAST OF LEADING HIV DRUGS, THROUGH 2018 ($ BILLIONS)
    • TABLE 36: HIV MARKET SHARE BY LEADING DRUGS (%)
    • TABLE 37: MARKET DRIVERS AND RESTRAINTS OF THE LEADING ARV DRUGS
    • TABLE 38: ONGOING CLINICAL TRIALS OF NNRTI DRUGS IN DEVELOPMENT
    • TABLE 39: ONGOING CLINICAL TRIALS OF STR FDC DRUGS
    • TABLE 40: ONGOING CLINICAL TRIALS OF EMERGING THERAPIES
    • TABLE 41: OVERVIEW OF ARV DRUGS IN DEVELOPMENT
    • TABLE 42: HIV RAPID TESTS ADVANTAGES AND DISADVANTAGES BY CLIA* COMPLEXITY AND GENERATION
    • TABLE 43: FDA APPROVED ANTIBODY HIV TESTS
    • TABLE 44: FDA APPROVED ANTIGEN-ANTIBODY COMBO TESTS
    • TABLE 45: CD4 TESTS IN THE MARKET
    • TABLE 46: LIST OF MARKETED VIRAL LOAD TESTS
    • TABLE 47: HIV/AIDS DIAGNOSTICS PIPELINE
    • TABLE 48: HIV DIAGNOSTICS MARKET BY TYPES OF TESTS, THROUGH 2018 ($ BILLIONS)
    • TABLE 49: HIV DIAGNOSTICS MARKET SHARE BY TYPES OF TESTS, 2012-2018 (%)
    • TABLE 50: CD4 TESTING MARKET SHARE IN SEVEN SUB-SAHARAN AFRICAN COUNTRIES, 2012 (%)
    • TABLE 51: GLOBAL DEMAND FOR CD4 TESTING, 2012-2018 (MILLIONS)
    • TABLE 52: GLOBAL DEMAND FOR VIRAL LOAD TESTING, 2012-2018 (MILLIONS)
    • TABLE 53: MARKET DRIVERS AND RESTRAINTS FOR HIV TESTING PRODUCTS
    • TABLE 54: CLINICAL TRIALS TESTING DRUG-BASED PREP, 2014 AND 2015
    • TABLE 55: ONGOING CLINICAL TRIALS OF MICROBICIDES, 2014 AND 2015
    • TABLE 56: EVOLUTION OF WHO GUIDELINES WITH REGARDS TO PMTCT, 2006-2013
    • TABLE 57: SELECTED ON-GOING TRIALS ON PMTCT, 2013-2017
    • TABLE 58: TYPE OF HIV VACCINES
    • TABLE 59: ONGOING CLINICAL TRIALS OF PROPHYLACTIC HIV VACCINES
    • TABLE 60: ONGOING CLINICAL TRIALS FOR THERAPEUTIC HIV VACCINES
    • TABLE 61: RETENTION TO TREATMENT (%)
    • TABLE 62: FIRST-LINE VS. SECOND-LINE TREATMENT MEDIAN PRICE, 2012 (IN $US PER PERSON PER YEAR)
    • TABLE 63: CHALLENGES AND OPPORTUNITIES IN THE GLOBAL HIV MARKET
    • TABLE 64: MAJOR DRIVERS AND RESTRAINTS IN THE GLOBAL HIV MARKET
    • TABLE 65: HIV THERAPEUTICS MARKET SHARE BY LEADING COMPANIES, 2012-2018 ($ BILLIONS)
    • TABLE 66: GLOSSARY
    • TABLE 67: ABBREVIATIONS

LIST OF FIGURES

  • SUMMARY FIGURE: GLOBAL HIV MARKET, 2012-2018 ($ BILLIONS)
    • FIGURE 1: ARV DRUGS SALES REVENUE BY GEOGRAPHIC REGIONS, 2012-2018 ($ BILLIONS)
    • FIGURE 2: SALES REVENUE OF ARV DRUGS IN EU5 COUNTRIES ($ BILLIONS)
    • FIGURE 3: SALES REVENUE OF ARV DRUGS IN LEADING ASIAN MARKETS, 2012-2018 ($ BILLIONS)
    • FIGURE 4: GENERIC VS. BRANDED ARV DRUGS GLOBAL SALES REVENUE, 2012-2018 ($ BILLIONS)
    • FIGURE 5: GENERIC ARV DRUGS GLOBAL SALES REVENUE GROWTH ($ MILLIONS/%)
    • FIGURE 6: HIV THERAPEUTICS MARKET BY DRUG CATEGORY 2012-2018 (%)
    • FIGURE 7: HIV MARKET SHARE BY LEADING DRUGS (%)
    • FIGURE 8: RANKING (BY MARKET SHARE) OF LEADING ARV DRUGS, 2012-2018
    • FIGURE 9: NUMBER OF CLINICAL TRIALS BY DEVELOPMENTAL PHASE
    • FIGURE 10: GLOBAL HIV THERAPEAUTICS MARKET ANALYSIS
    • FIGURE 11: HIV THERAPEUTICS MARKET SHARE BY LEADING COMPANIES (%) 156
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